GMP Guidelines definition

GMP Guidelines means then-current applicable Good Manufacturing Practices guidelines and regulations of the FDA.
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GMP Guidelines means Volume 4 of the Rules Governing Medicinal Products in the European Union, EU Guidelines for Good Manufacturing Process for Medicinal Products for Human and Veterinary Use.
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Examples of GMP Guidelines in a sentence

  • In agreement with Chapter 7 of Part I of the EU GMP Guidelines, a written agreement has to be signed among the parties establishing the corresponding responsibilities.

  • The outsourcing of the placing of the safety features on a packaged medicinal product can be contracted to another manufacturer in line with Chapter 7 of Part I of the EU GMP Guidelines, as long as they have a manufacturing authorisation (MIA).

  • For each POP or each matrix that will be analyzed for the first time in a POPs laboratory, the laboratory must demonstrate its capabilities on an objective, internationally agreed basis.Regarding monitoring of POPs concentration in humans, according to the GMP Guidelines, there will be one pooled mothers milk sample collected per country.

  • The contracting manufacturer must also make a statement confirming compliance with Annex 16 Appendix 1 of the EU GMP Guidelines available to the Qualified Person certifying the final product.

  • The project will also allow national laboratories to improve their ability to analyse POPs according to international standards consistent with GMP Guidelines, will develop detailed guidelines, protocols and manuals, and will facilitate reporting under the GMP.

  • Other pack label text will be identical for both TXA and placebo treatments and will be in compliance with Annex 13 of Volume 4 GMP Guidelines.

  • This regional monitoring plan will ensure frequent generation of data and input into the regional and global monitoring plans, which will feed the report to the Stockholm Convention ‘s Conference of the Parties.The GMP Guidelines recommends that 15‐20 sites per region are equipped with passive air samplers (PAS).

  • Tourism products are information intensive, the actual services taking place in the physical world.

  • ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE APPENDIX VI ASEAN GUIDELINES FOR COSMETIC GOOD MANUFACTURING PRACTICE PREAMBLE The GMP Guidelines have been produced to offer assistance to the cosmetic industry in compliance with the provisions of the ASEAN cosmetic Directive.

  • However, the implementation of internationally accepted standards such as the WHO GMP Guidelines (2) is currently not mandatory in all countries.

Related to GMP Guidelines

  • 2%/25% Guidelines has the meaning set forth in Section 13.

  • Program Guidelines means any and all GLO-approved documents reflecting specific rules and regulations governing the implementation of the Program.

  • ECB €STR Guideline means Guideline (EU) 2019/1265 of the European Central Bank of 10 July 2019 on the euro short-term rate (€STR) (ECB/2019/19), as amended from time to time;

  • Design Guidelines means the Fernkloof Estate architectural design guidelines to control all aspects of design and landscaping of any development within the Fernkloof Estate dev elopment, as amended from time to t ime in terms of the constitution of the MPOA or as required by the Council , a copy of the current draft which i s av ailable for inspection at the offices of the Association;

  • Procurement Guidelines means the “Guidelines: Procurement under IBRD Loans and XXX Credits” published by the Bank in May 2004 and revised in October, 2006.

  • Applicable Guidelines means the policies of the Bank governing the selection and Contract award process as set forth in this RFP.

  • Guidelines means the Instructions to Authors available on the Xxxxxxx Science website, as well as the Aims & Scope applicable to the relevant Xxxxxxx Science publication). Xxxxxxx Science’s nominated service provider, Xxxxxxx Science, offers English language support services which Assignor may elect to utilise in respect of the Work by completing the applicable box in Schedule 1: Details of the Work. The provision of such services by Xxxxxxx Science shall be subject to Xxxxxxx 2 [v.122016] Science’s prevailing terms and rates relating to such type of optional support.

  • Operating Guidelines means the guidelines for the creation and redemption of Units of a class as set out in the schedule to each Participation Agreement as amended from time to time by the Manager with the approval of the Trustee, and where applicable, with the approval of HKSCC and the Conversion Agent, and following consultation, to the extent reasonably practicable, with the relevant Participating Dealers subject always, in respect of the relevant Operating Guidelines for a Participating Dealer, any amendment being notified in writing by the Manager in advance to the relevant Participating Dealer. Unless otherwise specified, references to the Operating Guidelines shall be to the Operating Guidelines for the relevant Sub-Fund applicable at the time of the relevant Application.

  • Federal poverty guidelines means the poverty guidelines published annually in the federal register by the United States department of health and human services under its authority to revise the poverty line under section 673(2) of subtitle B of title VI of the omnibus budget reconciliation act of 1981, 42 USC 9902.

  • Fitch Guidelines means the guidelines, as may be amended from time to time, in connection with Fitch’s ratings of the VMTP Shares.

  • Modification Guidelines has the meaning provided in Section 2.1(a) of this Single Family Shared-Loss Agreement.

  • Consultant Guidelines means the “Guidelines: Selection and Employment of Consultants by World Bank Borrowers” published by the Bank in May 2004 and revised in October 2006.

  • Valuation Guidelines means the valuation guidelines adopted by the Board, as may be amended from time to time.

  • Treasury guidelines means any guidelines on supply chain management issued by the Minister in terms of section 168 of the Act;

  • User Guide means such user guide or document issued or prescribed by us, through any medium, setting out instructions on the use of the EB Services;

  • Investment Guidelines means the investment guidelines approved by the Board, a copy of which is attached hereto as Exhibit A, as the same may be amended, restated, modified, supplemented or waived pursuant to the approval of a majority of the entire Board (which must include a majority of the Independent Directors).

  • Program Guide The Residential Funding Seller Guide for mortgage collateral sellers that participate in Residential Funding's standard mortgage programs, and Residential Funding's Servicing Guide and any other subservicing arrangements which Residential Funding has arranged to accommodate the servicing of the Mortgage Loans.

  • Leasing Guidelines means the guidelines approved in writing by Lender, from time to time, with respect to the leasing of the Property. The following are the initial Leasing Guidelines:

  • Consulting Guidelines means the Guidelines on the Use of Consultants by Asian Development Bank and its Borrowers (2010, as amended from time to time);

  • Credit Guidelines means the policies of Credit Acceptance, relating to the extension of credit to automobile, light-duty truck, minivan and/or sport utility dealers and consumers in respect of retail installment contracts for the sale of automobiles, light-duty trucks, minivans and/or sport utility vehicles including the policies for determining creditworthiness of such dealers and consumers and otherwise relating to the extension of credit to dealers and consumers and the maintenance of installment sale contracts, as in effect on the Cut-off Date and as amended from time to time in accordance with the Basic Documents or in accordance with Applicable Law, attached hereto as Exhibit H.

  • User Guides means Sprinklr materials made available to Customer through the support portal to assist users of the Platform, as such materials may be updated during the Term.

  • Bidding Guidelines means the “Tariff Based Competitive-Bidding Guidelines for Transmission Service” and “Guidelines for Encouraging Competition in Development of Transmission Projects” issued by Government of India, Ministry of Power dated 13th April 2006 under Section – 63 of Electricity Act and as amended from time to time;

  • Anti-Corruption Guidelines means the “Guidelines on Preventing and Combating Fraud and Corruption in Projects Financed by IBRD Loans and XXX Credits and Grants”, dated October 15, 2006.

  • Program Requirements means certain minimum program entry requirements as well as ongoing program requirements, to be fulfilled by Partner, some of which are general PartnerEdge requirements, some of which are specific for the “Sell Engagement” and some of which are specific for the different “Cloud” Product Families, including, without limitation payment of the Program Fee(s), meeting certain minimum annual revenue requirements, upholding a Sell Authorization for at least one “Cloud” Product Family and other requirements as set out in detail in the PartnerEdge Program Guide and the RSPI.

  • Policies and Procedures means the written policies and procedures of the Client in any way related to the Services, including any such policies and procedures contained in the Organic Documents and the Offering Documents.

  • Rating Agency Guidelines means the Fitch Guidelines and any Other Rating Agency Guidelines as they exist from time to time.